TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	35	35
Material Fragmentation	28	28
Leak/Splash	25	25
Incorrect Measurement	10	10
Crack	8	8
Difficult to Insert	8	8
Adverse Event Without Identified Device or Use Problem	6	6
Uncoiled	6	6
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Sticking	4	4
Material Rupture	3	3
Entrapment of Device	3	3
Material Integrity Problem	3	3
Connection Problem	3	3
Appropriate Term/Code Not Available	2	2
Fracture	2	2
Fluid/Blood Leak	2	2
Packaging Problem	1	1
Insufficient Information	1	1
Defective Device	1	1
Split	1	1
Unable to Obtain Readings	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Device Alarm System	1	1
Malposition of Device	1	1
Disconnection	1	1
Incomplete or Missing Packaging	1	1
Mechanical Jam	1	1
Material Twisted/Bent	1	1
Device Operates Differently Than Expected	1	1
Physical Resistance	1	1
False Reading From Device Non-Compliance	1	1
Misconnection	1	1
Improper Device Output	1	1
Improper or Incorrect Procedure or Method	1	1
Failure to Advance	1	1
Retraction Problem	1	1
Delamination	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	52	52
No Clinical Signs, Symptoms or Conditions	50	50
No Known Impact Or Consequence To Patient	19	19
Foreign Body In Patient	7	7
Insufficient Information	4	4
Device Embedded In Tissue or Plaque	4	4
Ischemia	4	4
Hemorrhage/Bleeding	3	3
Infarction, Cerebral	2	2
No Information	2	2
No Patient Involvement	2	2
Vascular Dissection	2	2
Hematoma	1	1
Air Embolism	1	1
Occlusion	1	1
Thrombosis	1	1
Sudden Cardiac Death	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ICU Medical, Inc.	II	Dec-22-2018